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Time Restricted Eating for Obstructive Sleep Apnea

This study is looking at whether "time restricted eating" (TRE) can help people with obstructive sleep apnea (OSA). OSA is a common sleep disorder linked to heart and metabolism problems like high blood sugar and diabetes. While current treatments for OSA help with blood pressure, they don't always improve these other metabolic issues. This study will compare TRE, where you eat all your daily calories within an 8-10 hour window, to your usual eating habits. Researchers want to see if TRE can improve your daily blood sugar, cholesterol levels, and the severity of your sleep apnea after 12 weeks. You may be able to join if you are 18-70 years old, own a smartphone, and currently eat for 12 hours or more each day. The study aims to enroll 80 participants, but its current status is unclear.

Study design
This is an interventional study, meaning participants will receive a specific intervention (time restricted eating). It plans to enroll 80 participants.
What's involved
You would have an initial visit for blood tests, vital checks, questionnaires, and to have a continuous glucose monitor and activity tracker applied. For two weeks, you would track your food intake using a smartphone app. The primary outcomes are measured at 12 weeks.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for at least 12 weeks after starting the intervention to measure changes in glucose, cholesterol, and OSA severity.

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NCT06047496

Time Restricted Eating in Sleep Apnea

Recruiting
EARLY_PHASE1Ages 18–70InterventionalTreatment
University of California, San Diego
~80 participants
Updated 2024-01-16 on ClinicalTrials.gov
What's tested:Time restricted eating

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Effect of TRE vs SE on change in mean daily glucose level
Measured over 12 weeks
+3 more outcomes measured

Conditions

Time Restricted Eating
Obstructive Sleep Apnea

Explore related trials

Obstructive Sleep Apnea

Where it's being run

1 sites across 1 states
California1

Study leadership

  • Omar Mesarwi, MD · PRINCIPAL_INVESTIGATOR · University of California, San Diego

Who to contact

Pamela DeYoung, RPSGT
[email protected]
(858) 246-2154
Email the study team

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Eligibility criteria

Inclusion

Provision of signed and dated informed consent form;
Stated willingness to comply with all study procedures and availability for the duration of the study;
Be of appropriate age (18-70);
Own a smartphone (Apple iOS or Android OS);
Have a baseline eating period ≥12 hours/day and sufficient logging on the myCircadianClock app;
If participants are on cardiovascular medications (HMG CoA reductase inhibitors (statins), other lipid-modifying drugs, anti-hypertensives) no dose adjustments will be allowed during the study period;
Have untreated moderate to severe obstructive sleep apnea (OSA, apnea-hypopnea index ≥15 events/hr); and
Agree to adhere to Lifestyle Considerations (see section 5.3) throughout study duration\]

Exclusion

Participants with type 1 or type 2 diabetes mellitus who are taking insulin or sulfonylureas, or any participant with a history of hypoglycemia unawareness
OSA with evidence of significant sleepiness, as defined by either a) Epworth Sleepiness Score ≥15, or b) motor vehicle accident due to excessive sleepiness within the past year
BMI \>40 kg/m2
Uncontrolled hypertension
Active tobacco or illicit drug use
Pregnant or breastfeeding women
Currently enrolled in a weight-loss or weight-management program
Currently on a special or prescribed diet for other reasons (e.g., Celiac disease)
Currently taking any medication that is meant for weight loss, or has known effect on appetite suppression
History of eating disorder(s)
History of surgical intervention for weight management
Chronic kidney disease
Treatment for active inflammatory and/or rheumatologic disease and cancer
Unrevascularized cardiovascular disease
Liver cirrhosis and/or significant alterations in liver function
History of (a) thyroid disease requiring dose titration of thyroid replacement medication(s) within the past 3 months (i.e., hypothyroidism on a stable dose of thyroid replacement therapy is not an exclusion)
Shift workers with variable (e.g., occasionally nocturnal) hours
Traveling outside the US
History of HIV/AIDS
Uncontrolled psychiatric disorder
Other safety concern based on MD judgement

What this trial measures

  • Effect of TRE vs SE on change in mean daily glucose level12 weeks

    Change in mean daily glucose level over the study duration (measured in mg/dL), derived from continuous glucose monitoring (CGM), is the primary outcome.

  • Effect of TRE vs SE on change in serum LDL cholesterol12 weeks

    Change in serum LDL (mg/dL), based on fasting blood draws, will be compared between TRE and SE groups.

  • Effect of TRE vs SE on change in OSA severity12 weeks

    Change in OSA severity (apnea-hypopnea index, number of events per hour) will be compared versus pre-enrollment data.

  • Effect of TRE on quality of life12 weeks

    Change in quality of life, based on the Short Form (36) Health Survey, will be compared in TRE and SE groups. This survey is a patient-reported scale measuring overall health. It features eight scaled scores, where the scores are the weighted sums in each section (vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, and mental health). Scores range from 0-100 where lower scores mean more disability, and higher scores mean higher disability.